Regulatory CMC Expert
CSL Behring
Tokyo, JP
6 日前
  • Develops and executes CMC strategies collaborating with global CMC RA member for development products and / or life-cycle management of established products.
  • Prepare CMC regulatory dossiers (e.g. CTD) for development products and / or established products in accordance with Japanese regulations and requirements.
  • Executes regulatory actions and communication with global / regional functions for Business / Marketing License maintenance as a marketing authorization holder.
  • Executes negotiations, meetings and consultations with Japanese Health Authorities for development products and / or established products from CMC points of view.
  • Interacts with Global Regulatory Leads (GRLs) and local regulatory leads. 1 Serve as regional regulatory strategist for allocated product pipelines.
  • Develop regulatory CMC strategies considering regional requirements, category of applicable submission, scheduling and priority setting.

    Ensure all local regulatory activities are in alignment with the strategic direction of the GRAST. Contribute to a GRAST strategy setting providing regional CMC strategy.

    Participate in GRAST meetings in charge. 2 Contribute to the compilation of relevant high quality documents for submissions for development products and / or established products in Japan, including new applications and partial change application, minor change notification, etc.

    and responses to questions, according to agreed schedules while taking into account regional regulatory requirements. Ensure that dossiers meet the content and format requirements for the Japanese HAs.

    Based on submission overviews, responsible for preparation and compilation of regional parts of CMC submission dossiers, e.

    g. CTD CMC parts, including application form. 3 Business / Marketing License maintenance Plan necessary actions and timeline for regular license updates.

    Communicate well with appropriate regional regulatory offices and prepare required documents for the licenses updates. Maintain SOP for the licenses and ensure CSLB Japan (incl.

    branch) follows it. 4 In accordance with Global strategy, support to execute the negotiation, meetings and consultation, such as informal and formal consultation etc.

    for CMC issues / matters with Japanese Health Authorities. 5 Responsible for performing new applications, and partial change application and minor change notifications required to fulfill regional regulatory requirement.

    Submit the relevant regulatory documents to the Japanese HAs in a timely manner. Communicate submission dates and approval dates to stakeholders, as applicable.

    Responsible for the overall coordination and dispatch / submission of responses to HAs questions directly to HAs. Support the GRLs for the CMC strategy, planning and preparation of response for complex scientific questions requiring product expertise and contacting internal stakeholders.

    Coordinate and participate at meetings with HAs. 6 Act as a Subject Matter Expert on regional, regulatory procedures and HA requirements 7 Develop and maintain effective working relationships with the Japanese HAs demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring.

    Worker Type : Employee Worker Sub Type : Regular

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